FDA.reportPublic FDA data

Benzonatate

Product NDC
71205-887
11-digit product format
712050887
Labeler code
71205
Product ID
71205-887_65edfa43-d933-4390-bec4-b448916e4d5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211518
Marketing category
ANDA
Marketing start
2019-02-22
Substance
BENZONATATE
Active strength
200 mg/1
Pharmacologic classes
Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZONATATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P4DHS6ENR
Rxcui283417

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-887-00Benzonatate100 in 1 BOTTLECAPSULE1002
71205-887-10Benzonatate10 in 1 BOTTLECAPSULE102
71205-887-14Benzonatate14 in 1 BOTTLECAPSULE142
71205-887-15Benzonatate15 in 1 BOTTLECAPSULE152
71205-887-20Benzonatate20 in 1 BOTTLECAPSULE202
71205-887-21Benzonatate21 in 1 BOTTLECAPSULE212
71205-887-30Benzonatate30 in 1 BOTTLECAPSULE302
71205-887-55Benzonatate500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-887-00EA - Each71205-887902c4d56-fdac-4366-93cd-643fd77bd4c212021-11-09
71205-887-10EA - Each71205-8878be849fe-48d5-40f9-9882-ed0be0d4eae812021-11-09
71205-887-14EA - Each71205-88748a18ba8-8986-4bd2-a773-7eca22035d2512021-11-09
71205-887-15EA - Each71205-887d885b95c-454c-4b3a-baf7-d5d0abef8cf312021-11-09
71205-887-20EA - Each71205-887bfe44fbf-da8d-4cb5-9156-028326d8dbaf12021-11-09
71205-887-21EA - Each71205-887f1842315-599e-4c86-87a7-5294b5144d9b12021-11-09
71205-887-30EA - Each71205-88771f8052d-5862-4e2a-bbfc-36a6b3f9a3dd12021-11-09
71205-887-55EA - Each71205-8874f93b3e5-2552-4c83-b2e2-bbf9e088138a12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-887BENZONATATE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 8 package rows20220409_f4337699-3279-4c08-94f4-caba6d866f63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNf4337699-3279-4c08-94f4-caba6d866f632
283417benzonatate 200 MG Oral CapsuleSCDf4337699-3279-4c08-94f4-caba6d866f632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-887-0071205088700100 CAPSULE in 1 BOTTLE (71205-887-00) 100 capsule2021-09-170000-00-00NoNoCurrent
71205-887-107120508871010 CAPSULE in 1 BOTTLE (71205-887-10) 10 capsule2021-09-170000-00-00NoNoCurrent
71205-887-147120508871414 CAPSULE in 1 BOTTLE (71205-887-14) 14 capsule2021-09-170000-00-00NoNoCurrent
71205-887-157120508871515 CAPSULE in 1 BOTTLE (71205-887-15) 15 capsule2021-09-170000-00-00NoNoCurrent
71205-887-207120508872020 CAPSULE in 1 BOTTLE (71205-887-20) 20 capsule2021-09-170000-00-00NoNoCurrent
71205-887-217120508872121 CAPSULE in 1 BOTTLE (71205-887-21) 21 capsule2021-09-170000-00-00NoNoCurrent
71205-887-307120508873030 CAPSULE in 1 BOTTLE (71205-887-30) 30 capsule2021-09-170000-00-00NoNoCurrent
71205-887-5571205088755500 CAPSULE in 1 BOTTLE (71205-887-55) 500 capsule2021-09-170000-00-00NoNoCurrent